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Session 4
Session Chair(s)
Sabine Brosch, PharmD, PhD, MPharm
Data Protection Officer
European Medicines Agency, Netherlands
Session 4 will focus on challenges in coding patient safety data based on specific examples of medication error reports and how this can be addressed using MedDRA. Important onsiderations in relation to handling of medication errors and product quality issues will be presented from an FDA perspective. Coding, analysis and data presentation of medication errors in the context of risk management and pharmacovigilance will be also addressed. Actions agreed as a result of the Medication Error Workshop held at the EMA in February 2013 will conclude the discussions of this Information Day. Specific questions from the audience will be addressed as part of a panel discussion.
Speaker(s)
A Patient Safety Perspective of Medication Error Incident Reports and Coding Challenges
David Cousins
National Patient Safety Agency, United Kingdom
MedDRA Coding of Medication Error Incident Reports Based on Practical Examples
Sarah Vaughan
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Head of Vigilance Operations
Medication Errors
Heather Sutcliffe
Health Canada, Canada
Director, Marketed Health Products Safety & Effectiveness Information Bureau
Medication Errors versus Quality Issues
Sonja Brajovic, MD
FDA, United States
Medical Officer, OSE, CDER
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